|Número de publicación||US8210085 B2|
|Tipo de publicación||Concesión|
|Número de solicitud||US 12/548,984|
|Fecha de publicación||3 Jul 2012|
|Fecha de presentación||27 Ago 2009|
|Fecha de prioridad||27 Ago 2009|
|También publicado como||CA2772337A1, CN102596057A, EP2470083A1, US8733223, US20110048216, US20120272817, US20140290470, WO2011025926A1|
|Número de publicación||12548984, 548984, US 8210085 B2, US 8210085B2, US-B2-8210085, US8210085 B2, US8210085B2|
|Inventores||David C. Lindh, SR., Jason T. Perkins, Krasimira Hristov, Jesse G. Nawrocki, Robert J. Tannhauser|
|Cesionario original||Ethicon, Inc.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (38), Otras citas (1), Citada por (4), Clasificaciones (8), Eventos legales (1)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
The present application is related to commonly assigned U.S. patent application Ser. No. 12/549,046, entitled “Barbed Sutures Having Pledget Stoppers and Methods Therefor,” (ETH5566USNP), filed on even date herewith, the disclosure of which is hereby incorporated by reference herein.
1. Field of the Invention
The present invention generally relates to surgical sutures, and more specifically relates to automated systems and methods for making braided barbed sutures.
2. Description of the Related Art
Surgical sutures are used to close wounds and surgical incisions, and to repair damaged muscles, vessels, and tissue. Typically, a needle is attached to one end of a surgical suture, and the needle is drawn through tissue to form one or more loops holding the tissue together. The suture is subsequently tied off in one or more knots so that the tissue will remain drawn together.
There have been a number of attempts directed to improving sutures. For example, U.S. Pat. No. 4,546,769 to Planck et al. discloses a suture including a jacket made of a tubular braided structure, such as non-crimped yarns, and a core located within the jacket containing crimped fibers. The jacket is formed by braiding the non-crimped yarns around the core, which provides a suture that is easier to bend, easier to handle, and that makes better knots.
Although sutures are very effective for closing wounds, there are a number of challenges associated with using conventional sutures. Many of these challenges are directly related to the knots used to secure sutures in place. If the knots are not tied properly, defects may arise including slippage, knot breakage, and re-opening of the wound. In addition, using knots to secure sutures may distort tissue, restrict blood flow, increase the formation of scars, impede wound healing, and result in infection.
In response to the above-noted deficiencies associated with conventional sutures, sutures having barbs have been developed. Unlike conventional sutures, barbed sutures have projecting barbs that allow the suture to be used to close wounds, approximate tissue, tighten tissue, and attach prosthetic devices without using knots. U.S. Pat. No. 5,931,855 discloses barbed sutures that are used for cosmetic procedures such as brow-lifts and face-lifts. Fixing conventional sutures with knots requires the knots to be pushed down toward the tissue to assure proper tensioning and fixation of the sutures. In contrast, barbed sutures achieve proper tensioning and fixation by applying tension to the suture.
One problem associated with barbed sutures is that the barbs may delaminate or separate from the core of the suture, which may lead to device failure. In response to problems encountered with barbed sutures, braided barbed sutures having more durable barbs have been developed. In one embodiment of commonly assigned U.S. Patent Application Publication No. 2007/0005110, the disclosure of which is hereby incorporated by reference herein, at least one barbed filamentary element is intertwined along its length with a plurality of unbarbed filamentary elements, and the plurality of barbs extend outwardly beyond the unbarbed filamentary elements. In one embodiment, a braided barbed suture made using the methods disclosed in the '110 publication had a 96% improvement in holding strength compared to a barbed monofilament. Thus, superior holding strength was achieved without requiring the use of knots.
Other efforts for making braided, barbed sutures include manually delivering a barbed filament into a winding filament assembly. This approach requires an operator to adhere to a complex series of steps including running a braider to form a first length of unbarbed suture, turning the braider off, positioning a barbed filament at the braider eyelet where the filaments wind together, then turning the braider back on and allowing the winding filaments to draw the barbed filament into the braid. This approach provides very little control over the twisting of the barbed filament as it is drawn into the braid, which often results in undesirable braiding quality. This approach is also extremely labor intensive because an operator is required to continually turn the braiding equipment on and off while adjusting the position of the barbed filament. In addition, the barbed insert material being braided is greatly affected by the winding filaments themselves or by the vibration created as a result of winding. The vibration generated by the braiding equipment can result in the barbed material whipping, twisting, getting caught in the filaments, or accumulating undesirable rotation.
In spite of the above advances, there remains a need for improved systems and methods for making braided, barbed sutures, including automated systems and methods for making braided, barbed sutures. There also remains a need for improved systems and methods that consistently produce braided barbed sutures meeting exacting standards, and that transform barbed inserts having barbs in a single plane into braided barbed sutures having barbs in multiple planes.
In one embodiment, a system for making braided barbed sutures includes a filament winding assembly adapted to wind a plurality of filaments around an object, such as a barbed insert, and a guide assembly including at least one barbed insert dispenser opening defining a passageway for orienting a barbed insert. In one embodiment, the passageway is an elongated slit having a greater width than height. The guide assembly is preferably adapted to dispense at least one barbed insert from the dispenser opening and into the filament winding assembly so that the plurality of filaments may be wound about the barbed insert. The passageway of the dispenser opening is preferably adapted to allow longitudinal movement of the at least one barbed insert relative to the passageway while simultaneously prevented twisting movement of the at least one barbed insert relative to the passageway. In other words, the passageway is sized and shaped to enable the barbed insert to move freely along its longitudinal axis relative to the passageway. However, the passageway has a size and shape that substantially conforms to the size and shape of the barbed insert so that the barbed insert is constrained from rotating about its longitudinal axis relative to the passageway when the barbed insert is passing through the passageway.
Although the present invention is not limited by any particular theory of operation, it is believed that providing a passageway, such as an elongated slit, for dispensing a barbed insert provides enhanced control over the orientation and configuration of the barbed insert as it is introduced into the filament winding assembly. During a braiding operation, a barbed insert may twist, loop and/or rotate uncontrollably about its longitudinal axis as it is introduced into the filament winding assembly, which may result in the formation of braided barbed sutures having inconsistent quality. The present invention seeks to reduce the number of uncontrollable variables found in conventional braiding systems by more directly controlling the orientation and configuration of the barbed insert as it is introduced into the filament winding assembly. The present invention also provides an automated system that does not require continuous human oversight.
In one embodiment, a barbed insert includes an elongated core having a leading end, a trailing end, and a longitudinal axis extending between the leading and trailing ends thereof. The barbed insert preferably includes at least one barb, and preferably a plurality of barbs extending outwardly from the core. In one embodiment, the plurality of barbs includes a first set of barbs extending in a first direction, and a second set of barbs extending in an opposite second direction. In one embodiment, at least one set of barbs may taper outwardly between a first end and a second end, which preferably facilitates passage of the barbed suture through tissue.
In one embodiment, the passageway of the barbed insert dispenser opening desirably controls and/or prevents rotation of a barbed insert relative to the passageway when the barbed insert is in contact with the passageway and as the barbed insert is introduced into the filament winding assembly. In one embodiment, the barbed insert dispenser opening may be rotated as the barbed insert is dispensed therefrom for imparting rotation to the section of the barbed insert in contact with the passageway. Thus, although the barbed insert will not rotate about its longitudinal axis relative to the passageway, the barbed insert may be rotated by the passageway to provide a twist to the barbed insert. In one embodiment, the passageway is rotated as the barbed insert is dispensed so that the filaments are helically wound about the barbed insert, which, in turn, may result in transforming a barbed insert having barbs in a single plane into a braided barbed suture having barbs projecting in multiple planes, such as approximately 360° around the perimeter of the core.
The system described herein is preferably automated so that braided barbed sutures having consistent characteristics and quality may be produced. In one embodiment, the system preferably includes a system controller having a central processing unit for controlling operation of the system. In one embodiment, the system controller controls operation of the filament winding assembly and the guide assembly. The system controller may have a first state in which the dispenser opening is stationary as a barbed insert is dispensed into the filament winding assembly. The system controller may have a second state in which the dispenser opening is rotated as the barbed insert is dispensed into the filament winding assembly for providing a twist to the barbed insert as filaments are wound around the core of the barbed insert.
In one embodiment, a plurality of barbed inserts having finite lengths are introduced in series into the filament winding assembly. In this embodiment, the guide assembly preferably comprises a plurality of cartridges, each of the cartridges including one of the dispenser openings defining a passageway (e.g. an elongate slit) for orienting one of the barbed inserts. Each of the barbed inserts is preferably loaded into one of the cartridges so that a leading end of each barbed insert projects from the passageway of the barbed insert dispenser opening associated therewith.
In one embodiment, the guide assembly also includes a magazine for holding the cartridges and the system controller includes a subroutine for introducing the cartridges one at a time into the filament winding assembly. In one embodiment, a first loaded cartridge is introduced into the filament winding assembly so that the barbed insert loaded therein may be drawn into the filament winding assembly for producing a first braided barbed suture. After the barbed insert has been drawn from the first cartridge, the cartridge may be automatically removed from the system. A second cartridge including a barbed insert loaded therein may then be advanced into alignment with the filament winding assembly so that the second barbed insert in the second cartridge may be drawn into the braid for forming a second braided barbed suture. The second empty cartridge is then dispensed, and the process is repeated for delivering a series of loaded cartridges to the filament winding assembly and removing empty cartridges from the system.
In one embodiment, each of the cartridges preferably includes an optical window for providing visual access to the barbed inserts loaded therein. The system controller preferably includes an optical sensor and/or optical equipment for determining whether barbed inserts are present in the cartridges. In one embodiment, after a barbed insert has been drawn from a cartridge, the optical sensor determines that the barbed insert has been removed and that the cartridge is empty. At this point, the optical sensor transmits a signal to the system controller, which, in turn, generates one or more signals for removing the empty cartridge from the system and advancing the next loaded cartridge into alignment with the filament winding assembly.
In one embodiment, each cartridge includes an outer surface and the guide assembly preferably includes a cartridge insertion rod that engages the outer surfaces of the respective cartridges for controlling movement of the cartridges. In one embodiment, each cartridge includes a lower end that is keyed and the cartridge insertion rod includes an upper end that is keyed for meshing with the keyed lower end of the cartridge. In one embodiment, the opposing keyed ends enable the cartridge insertion rod to hold the cartridge from rotating about its longitudinal axis as the barbed insert loaded therein is drawn into the filament winding assembly. In one embodiment, the cartridge insertion rod may rotate under the command of the system controller for rotating the cartridge and the dispenser opening associated with the cartridge, which, in turn, provides a twist to the barbed insert as the insert is drawn from the dispenser opening of the cartridge.
In one embodiment, a system for making braided barbed sutures includes a filament winding assembly having a plurality of filaments, and a guide assembly for guiding at least one barbed insert toward the filament winding assembly. The guide assembly desirably has a barbed insert dispenser opening, such as an elongated slit, adapted to enable longitudinal movement of the barbed insert through the barbed insert dispenser opening while simultaneously preventing twisting movement of the at least one barbed insert relative to the barbed insert dispenser opening. In one embodiment, the filament winding assembly desirably includes a braider eyelet for directing the plurality of filaments toward a braiding zone. The guide assembly is adapted to direct a leading end of at least one barbed insert into the braiding zone for winding the plurality of filaments around the at least one barbed insert for making a braided barbed suture.
In one embodiment, at least one barbed insert has a longitudinal axis, and the barbed insert dispenser opening is rotatable as the barbed insert is dispensed from the barbed insert dispenser opening for rotating the barbed insert about its longitudinal axis as the plurality of filaments are winding around the barbed insert.
In one embodiment, a method of making braided barbed sutures includes providing a filament winding assembly having a plurality of filaments, and providing at least one barbed insert for introduction into the filament winding assembly. The method preferably includes providing a barbed insert dispenser opening adjacent the filament winding assembly for dispensing the at least one barbed insert into the filament winding assembly. The barbed insert dispenser opening is preferably adapted to allow longitudinal movement of the at least one barbed insert relative to the barbed insert dispenser opening while simultaneously preventing twisting movement of the at least one barbed insert relative to the barbed insert dispenser opening. The method desirably includes dispensing the at least one barbed insert from the barbed insert dispensing opening and into the filament winding assembly. A plurality of filaments is preferably wound around the barbed insert as the barbed insert is dispensed from the barbed insert dispenser opening.
In one embodiment, the at least one barbed insert includes a core and at least one barb projecting outwardly from the core. In one embodiment, the barbed insert dispenser opening preferably defines an elongated slit having a size and a shape that substantially conforms to the size and shape of the at least one barbed insert. In one embodiment, when dispensing the at least one barbed insert, the barbed insert dispenser opening is preferably rotated for twisting the at least one barbed insert as the plurality of filaments are winding around the at least one barbed insert. This particular embodiment preferably transforms a barbed insert having barbs that lie in a single plane into a braided barbed suture having barbs projecting 360° around the perimeter of the core.
In one embodiment of the present invention, systems and methods are adapted to consistently incorporate insert materials into a multi-filament suture during braiding, which yields resultant device designs having inserts that are fully contained within the multi-filament braid, or resultant device designs having protrusions that extend out from the multi-filament braid in a single plane or in multiple planes. In one embodiment, barbed inserts of various sizes, shapes, materials or variations thereof may be incorporated into multi-filament sutures of various sizes and materials, including absorbable and non-absorbable materials. Novel braiding technologies such as those described herein provide a wide range of next generation suture-based devices. In one embodiment, the present invention provides for the fabrication of braided barbed devices in a full-scale manufacturing setting with consistent and repeatable results. The fully-automated features of the present invention eliminate the labor intensive aspect of delivering each barbed insert into the braid by hand.
In one embodiment, an individual barbed insert, having a finite distinct length, is placed into a cartridge and fed into a filament winding assembly during braiding. The result is a suture-based device having finite sections of braided barbed suture interposed between finite lengths of braided suture. In another embodiment, a continuous length of suture material having a barbed profile, like that of the individual barbed inserts, may be continuously fed from a spool through a guide and subsequently incorporated into the winding filaments during braiding, which provides a suture-based device comprised of a continuous length of braided barbed suture.
In one embodiment, the automated braiding equipment provides for braiding the winding filaments around a barbed insert with the desired protrusion of the barbs from the multi-filament suture. The automated braiding equipment enables a method of manufacture that consistently produces satisfactory braiding quality while significantly reducing the labor involved to achieve such devices. In one embodiment, a system operator may fill a magazine with loaded cartridges, program the desired braiding cycle parameters, and allow the automated braiding equipment to perform the braiding operation. Or, in the case of a continuous length of suture material having a barbed profile, the person operating the system may thread the lead end of a spool of barbed material through the guide and allow the suture filaments to wind around the barbed material until the barbed material runs out.
In one embodiment, the present invention also enables the manufacture of barbed suture devices with helically-shaped cores. The novel aspect of this resultant design is that the helical shape of the core can be controlled using the automated braiding equipment to create a fixation device that provides holding strength in 360° around the core.
In one embodiment, a magazine loaded with a plurality of cartridges is locked in place beneath a braider using a magazine tool. The braider is then turned on and a PLC-controlled cycle commences for delivering barbed inserts from the cartridges into the braid. At an appropriate time, a retractable gate is retracted and an air cylinder pushes the stack of cartridges toward the chamber for loading a lead cartridge in the chamber. The retractable gate then closes, isolating the loaded, lead cartridge in the chamber. A two-stage lift sequence may be initiated. During a first stage, an uplift rack with motor travels upward then stops. During a second stage, the uplift sequence allows a push rod to engage the bottom of the lead cartridge and initiate the upward travel of the rod and cartridge.
In one embodiment, as the cartridge approaches its maximum travel toward the winding filaments, but before the cartridge comes to a complete stop, the barbed insert is drawn out of the cartridge by the winding filaments. A fiber optic sensor detects when the barbed insert has been drawn out of the cartridge at which time the empty cartridge begins its downward travel. When the empty cartridge returns to the cartridge chamber, it is ejected and carried to a collection area via a cartridge ejection tube.
In one embodiment, a continuous length of suture material having a barbed profile is delivered through a guide and into a winding filaments assembly. The guide is adapted to deliver the barbed material to the winding filaments assembly. The lead end of the continuous length of barbed suture material is threaded through the guide and incorporated into the winding suture filaments. In one embodiment, the guide may be rotated as the continuous length of suture material is fed into the guide so that the resultant braided barbed suture will have a helical shape that is set by the braid itself. The present invention allows for braided barbed sutures having barbs or other protrusions present in a single plane or in multiple planes including a 360° helical design.
In one embodiment, a system for making braided barbed sutures includes a bullet-like cartridge adapted to receive barbed inserts having a finite length. In this embodiment, the cartridge is adapted to act as a vehicle for the delivery of a barbed insert into a braided multi-filament suture. The bullet-like cartridge includes a keyed slot at the bottom of the cartridge that prevents undesirable twisting motion of the barbed insert to enable braiding. The cartridge is affixed, and does not allow for the free movement of the insert as it is incorporated into the braid.
In one embodiment, the braider system includes a controller having timers, sensors, and cartridge deliver apparatus. The above-described controller is preferably combined with conventional braiding technology whereby the timers and sensors allow for a fully-automated, repeatable braiding cycle that enables the consistent formation of braided, barbed sutures. The cartridge deliver apparatus preferably allows for the physical delivery of the cartridge, which contains a barbed insert, to the suture filaments at desired suture length intervals. As the cartridge approaches its maximum travel toward the winding filaments, but before the cartridge comes to a complete stop, the barbed insert is desirably drawn out of the cartridge by the winding filaments themselves.
In one embodiment, the control system provides for control over variable motion/rotation, braiding speed, and cartridge delivery speed. In one embodiment, controlled rotation of the barbed insert during delivery into the suture filaments allows for a helical resultant device whereby the suture braid sets the twist of the core of the barbed insert via cartridge rotation.
In one embodiment, the braider system includes a cartridge magazine with retractable gate and ejection tube. The cartridge magazine with retractable gate and ejection tube preferably allows for a side-loading and bottom ejecting apparatus that enables delivery of a loaded cartridge into the suture filaments for braiding and the ejection of an empty cartridge after the barbed insert has been delivered into the braid.
In one embodiment, a braider system produces braided barbed sutures having a helical-shaped core with barbs protruding 360° around the core. The helical design preferably allows for barbs to engage 360° around the core rather than in a single plane. The 360° positioning of the barbs preferably increases the holding strength of the resultant device. The braider system of the present invention preferably enables an operator to transform a flat, barbed insert having barbs in a single plane into a multi-plane device. To date, such multi-plane devices were only achievable via methods such as cutting into monofilament sutures and twisting the resultant device or via injection molding.
In one embodiment, a braider system includes a rotatable guide for barbed inserts that accommodates a continuous length of suture material having a barbed profile, whereby the continuous length of suture material is fed from a spool and incorporated into a braid. In one embodiment, a continuous length of suture material having a barbed profile may be fed through the rotatable guide, incorporated into the braid, and collected on a collection spool. The guide is desirably attached to the equipment by an appropriate substructure. The guide is preferably rotatable as the continuous barbed material is fed through it to create a periodic helical design of the resultant device whereby the suture filaments set the orientation of the continuous length of barbed suture material.
These and other preferred embodiments of the present invention will be described in more detail below.
The braider system 50 also desirably includes a cartridge ejection tube 78 for dispensing empty cartridges from the system after barbed inserts have been withdrawn from the cartridges by the braider system, and preferably after the cartridges have been returned to a position below the braider plate 58 by the lifting rack 76. The braider system also desirably includes a suture core 80, which provides increased tensile strength and controls elongation of the braided suture.
In one embodiment of the present invention, barbed inserts are loaded into cartridges and the loaded cartridges are advanced into the enclosed area 54 of the automated braider system. Once the barbed inserts are advanced into the enclosed area, filaments are preferably wound around the barbed inserts to make braided barbed sutures. The barbed inserts and filaments may be made of biocompatible absorbable materials, non-absorbable materials, and combinations of absorbable and non-absorbable materials. Preferred non-absorbable materials suitable for both the barbed inserts and the filaments are polypropylene, a polymer blend of polyvinylidene fluoride and polyvinylidene fluoride-co-hexafluoropropylene, polyethylene, polyvinylidene fluoride (PVDF), polyesters, polyethylene terephthalate, glycol-modified polyethylene terephthalate, polytetrafluoroethylene, fluoropolymers, nylons, etc. and the like, or copolymers of combinations thereof. Preferred absorbable polymeric materials suitable for both the barbed inserts and the filaments include polydioxanone, polyglactin, polyglycolic acid, copolymers of glycolide and lactide, polyoxaesters, and poliglecaprone. In certain preferred embodiments, these may include combinations of both absorbable and non-absorbable materials, especially for the filaments. In addition, metals or ceramics may be suitable for certain applications, such as instances where specific strength or corrosion resistance is necessary. In one preferred embodiment, the preferred material is a polymer blend of polyvinylidene fluoride and polyvinylidene fluoride-co-hexafluoropropylene material. In a highly preferred embodiment, the filament material is polyethylene terephthalate. In addition, any of these materials may have conventional surface modifications that include coatings, plasma treatments, therapeutics and the like.
In one embodiment, the barbed insert has barbs that are oriented at 180 degrees from one another. This orientation lends itself to having the cartridge opening accommodate barbs at 180 degrees from one another by having a cartridge opening that is shaped as an elongated slit (having a width greater than its height). However, the orientation of the barbed inserts is not limited to having barbs that are 180 degrees opposed from one another. An example would be a barbed insert having three sets of barbs, whereby each set of barbs is oriented 120 degrees from each other around the axis of the core. In this embodiment, the barbed insert dispenser opening of the cartridge may have a cross-section that accommodates this arrangement in a manner to maintain rotational alignment and prevent undesired rotation of the barbed insert around its core while allowing for longitudinal motion of the insert as it is drawn into the winding filaments. In one embodiment, systems and methods for making braided barbed sutures include loading one barbed insert into one barbed insert dispenser opening in preparation for its delivery into the winding filaments. In one embodiment, however, a single cartridge may have multiple openings/cross-sections to accommodate one barbed insert per cartridge opening or multiple barbed inserts in a single cartridge opening.
The second elongated half 216B of the cartridge 200 has one of the opposing grooves formed therein that defines the elongated slit 214. In one embodiment, the opposing groove that defines the elongated slit 214 preferably extends from the leading end 202 of the cartridge to the keyed end 212 of the cartridge 200. In one embodiment, the groove that defines the slit 214 includes a narrower stem-shaped section 226 that accommodates the core of the barbed insert at the second end 104 of the barbed insert. A main section 228 of the slit 214 is wider than the stem-shaped section 226 and is sized and shaped to accommodate the barbs on the first and second barbed sections of the barbed insert.
The braider system includes the retractable gate 252 that selectively opens and closes the cartridge chamber 250. In
The automated system 300 shown in
In one embodiment, the barbed suture is made using a non-absorbable polymeric material, and a non-absorbable multi-filament polyester suture, commonly sold under the trademark Ethibond Excel by Ethicon, Inc., with surgical needles attached to both ends of the suture. A pledget, such as a Teflon pledget, may be positioned in the middle of the polymeric anchoring section.
While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. As such, the scope of the present invention is to be limited only as set forth in the appended claims.
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|Clasificación de EE.UU.||87/34|
|Clasificación cooperativa||A61B17/06166, A61B2017/00526, D04C3/48, A61B2017/06176|
|Clasificación europea||D04C3/48, A61B17/06S|
|30 Sep 2009||AS||Assignment|
Owner name: ETHICON, INC., NEW JERSEY
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LINDH, DAVID C., SR.;PERKINS, JASON T.;HRISTOV, KRASIMIRA;AND OTHERS;SIGNING DATES FROM 20090928 TO 20090929;REEL/FRAME:023308/0186